(305 days)
Not Found
No
The document describes image processing for noise reduction but does not mention AI, ML, or any related concepts like neural networks, training data, or performance metrics typically associated with AI/ML devices.
No
The device aids in diagnosis by processing and enhancing CT images, rather than directly treating a condition.
No.
The device enhances CT images by reducing noise to assist radiologists, but it is explicitly stated that it is not for diagnostic interpretation and is not effective for lesions smaller than 3 mm.
Yes
The device is described as a "software package of a PACS server" that receives, processes, and transfers CT images. The description focuses solely on the software's function and does not mention any proprietary hardware components included with the device. While it connects to a LAN and a PACS server (which are hardware), the device itself is presented as the software running on or integrated into that existing infrastructure.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The SafeCT processes and enhances CT images, which are generated in vivo (within the living body) using radiation. It does not analyze samples taken from the body.
- Intended Use: The intended use is for "networking, communication, processing and enhancement of CT images" to assist radiologists in reaching a diagnosis. This is image processing and display, not laboratory testing of biological samples.
Therefore, the SafeCT falls under the category of medical imaging software or a PACS component, not an IVD.
N/A
Intended Use / Indications for Use
The SafeCT is intended for networking, communication, processing and enhancement of CT images in DICOM format. It is specifically indicated for assisting professional radiologists and specialists in reaching their own diagnosis. The device processing is not effective for lesion, mass or abnormalities of sizes less than 3 mm. The SafeCT is not intended for use with or for diagnostic interpretation of Mammography images.
Product codes
LLZ
Device Description
The SafeCT is a software package of a PACS server, which is connected to the clinics' Local Area Network (LAN), receives, processes and transfers CT images, using the DICOM protocol. The processing enhances image quality by reduction of the image noise.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional radiologists and specialists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Its performance has been validated by comparing the image quality of phantom and clinical processed data to the image quality of the original (unprocessed) corresponding data. The results of the performance testing demonstrate the device safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K024028 SharpView
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(b)
Device Name Proprietary Device Name: SafeCT
Establishment Name and Registration Number of Submitter
Name: Medic Vision Brain Technologies Ltd. Corresponding Official: Dan Laor Sireni 6, Haifa 32972, Israel TEL: 972-4-8246632
DEC 1 4 2010